US6068617A - Needleless valve for use in intravenous infusion - Google Patents

Abstract

An IV port body defining an IV port includes a valve body configured as a luer fitting, and a movable valve member defining an outer periphery that is uninterrupted within the periphery is disposed in the valve body. The valve member is biased to a first configuration, wherein a passageway for fluid communication is not established through the valve body. Also, the valve member can be moved to a second configuration, wherein fluid communication through the body is permitted.

Description

RELATED APPLICATIONS

The present application is a continuation of and claims priority from U.S. patent application Ser, No. 08/612,875, now U.S. Pat. No. 5,645,538, for an invention entitled "Needleless Valve for use in Intravenous Infusion" filed March 12, 1996, which in turn is a continuation-in-part of Ser. No. 08/123,632 U.S. Letters Pat. No. 5,405,333, filed on Sep. 16, 1993 for an invention entitled "Liquid Medicament Bag With Needleless Connector Fitting Using Boat Assembly" which in turn is a continuation-in-part of Ser. 07/997,610 U.S. Pat. No. 5,391,150, filed on Dec. 28, 1992 for an invention entitled "IV Bag With Needleless Connector Ports."

FIELD OF THE INVENTION

The present invention relates generally to intravenous liquid medicament infusion equipment, and more particularly to needleless valves for use therein.

BACKGROUND OF THE INVENTION

One of the most widely used methods of medical therapy is the intravenous (IV) infusion of medicaments and/or nutrients into the bloodstream of a patient. Commonly, syringes or IV containers, such as bags, having at least one opening are used to hold the fluid to be infused. Many IV containers can have more than a single opening, to establish both a pathway for extracting fluid from the container and a pathway for injecting fluid into the container. The openings can be formed in the bottom seam of the container or in the side of the container, and the openings are blocked by membranes.

Ordinarily, to establish fluid flow through the opening the membrane is pierced by inserting a so-called IV spike into the opening. The spike is usually connected to a transparent drip chamber for visually verifying fluid flow and flow rate from the container (e.g., a bag), and the drip chamber in turn is connected to an IV line to the patient. Alternatively, a resealable membrane can cover one of the openings, and the resealable membrane can be punctured by the needle of a syringe to inject additional fluid from the syringe into the bag.

It has become apparent, however, that the use of "sharps" such as needles and spikes raises the possibility that a health care worker could inadvertently puncture the container/bag or himself with the needle or spike, and thus increase the risk of transmitting tragic diseases such as AIDS. Thus, the use of needles and other "sharps" should be avoided whenever possible in the health care environment.

Further, even though a spike may not necessarily be considered a "sharp" under all circumstances, the existing membrane arrangements requiring the use of a spike do not permit removal of the spike from the container (bag) until the contents of the bag are completely exhausted. This is because the hole a spike makes in a membrane is typically too large to permit the membrane to reseal. Thus, once inserted, a spike is not usually removed from an IV bag until the bag is empty, which can understandably limit use of the bag and its contents.

Accordingly, it is an object of the present invention to provide a needleless valve for use with IV components. Another object of the present invention is to provide a spikeless/needleless valve in combination with various IV components and configurations. Yet another object of the present invention is to provide a spikeless/needleless IV valve that is easy to use and cost-effective to manufacture.

SUMMARY OF THE INVENTION

A device for holding liquid medicament includes an IV component having an opening formed therein. A valve including a valve body is operably engaged with the opening, and the valve has a first position, wherein a passageway for fluid communication is established through the opening, and a second position, wherein fluid communication through the opening is not permitted. In accordance with the present invention, the valve includes a male valve element having a skirt disposed within the valve body and an engagement surface extending outwardly beyond the valve body for contacting a spikeless/needleless connector to cause the valve element to reciprocate relative to the IV component. The valve is biased to the second position and is engageable with the spikeless/needleless connector to establish the first position of the valve.

Preferably, the IV component is a component selected from the group of components consisting of: IV containers and bags, syringes, spikes, fluid lines, drip chambers, connector fittings, filters, Burette chambers, stopcocks, and multiport valves.

In another aspect of the present invention, a valve includes a hollow body defining a fluid passageway therethrough, and a resilient valve disc is positioned in the fluid passageway. The disc is biased to a closed configuration, wherein the disc blocks fluid flow through the fluid passageway, and the disc is movable to an open configuration, wherein fluid flow is permitted through the fluid passageway. Further, the valve includes a male valve element which is formed with a skirt and an engagement surface extending outwardly from the fluid passageway for contacting a spikeless/needleless connector. The spikeless/needleless connector can be advanced against the valve element to urge the valve element against the valve disc and thereby move the valve disc to the open configuration.

These and other aspects of the present invention can best be appreciated in reference to the accompanying drawings in which like numerals refer to like parts, and in which:

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of the IV bag of the present invention, shown in one intended environment;

FIG. 1A is a perspective view of a glass vial with reflex valve;

FIG. 2A is a cross-sectional view of one of the valves of the IV bag, as seen along theline 2--2 in FIG. 1, with the valve in the closed position;

FIG. 2B is a cross-sectional view of one of the valves of the IV bag, as would be seen along theline 2--2 in FIG. 1, with the valve in the open position;

FIG. 3 is an exploded view of the valve shown in FIG. 2A, with portions of the tamper-proof cap broken away, or shown in phantom for clarity;

FIG. 4A is a cross-sectional view of another one of the valves of the IV bag, as seen along theline 2--2 in FIG. 1, with the valve in the closed position;

FIG. 4B is a cross-sectional view as would seen along theline 2--2 in FIG. 1, with the valve in the open position;

FIG. 5 is a perspective view of a liquid medicament bag having a male and a female reflex valve, with portions of the bag broken away;

FIG. 6 is a cross-sectional view of the liquid medicament bag of the present invention, as seen along theline 6--6 in FIG. 5;

FIG. 7 is a cross-sectional view of the liquid medicament bag of the present invention, as seen along the line 7--7 in FIG. 5, with the valve in the closed configuration;

FIG. 8 is a cross-sectional view of the liquid medicament bag of the present invention, as would be seen along the line 7--7 in FIG. 5, with a female luer fitting shown in phantom engaging the valve, with the valve in the open configuration;

FIG. 9 is a perspective view of an alternate embodiment of the valve assembly for the liquid medicament bag of the present invention;

FIG. 10 is a perspective view of another alternate embodiment of the liquid medicament bag of the present invention, with the tamper-resistant caps shown in an exploded relationship with their respective valves;

FIG. 11 is an exploded cross-sectional view of yet another alternate embodiment of the liquid medicament bag of the present invention;

FIG. 12 is an exploded cross-sectional view of still another alternate embodiment of the liquid medicament bag of the present invention, with portions broken away, showing a valve of the present invention connected to a medicament bag by a luer fitting;

FIG. 13 is an exploded cross-sectional view of another alternate embodiment of the liquid medicament bag of the present invention, with portions broken away, showing a valve of the present invention connected to a medicament bag by a tubular connector;

FIG. 14 is a cross-sectional view of a male reflux valve of the present invention shown disposed in a male Luer fitting, with portions broken away for clarity;

FIG. 15 is a cross-sectional view of a male reflux valve disposed in a male Luer fitting which has been coaxially bonded to a female Luer fitting;

FIG. 16 is a cross-sectional view of a male Luer fitting with male reflux valve bonded to an annular fitting;

FIG. 17 is a cross-sectional view of a male Luer fitting with male reflux valve in combination with a check valve;

FIG. 18 is a cross-sectional view of a male Luer fitting with male reflux valve bonded to a barbed connector;

FIG. 19 is a cross-sectional view of a male Luer fitting with male reflux valve bonded to a stepped connector;

FIG. 20 is an enlarged cross-sectional view showing a valve element of the present invention having an angled contact surface;

FIG. 21 is a cross-sectional view of a male Luer fitting with male reflux valve bonded to a threaded connector;

FIG. 22 is a cross-sectional view of a male Luer fitting with male reflux valve bonded to a "T"-site connector;

FIG. 23 is a cross-sectional view of a male Luer fitting with male reflux valve bonded to a "Y"-site connector;

FIG. 24 is an exploded cross-sectional view showing a male Luer fitting and male reflux valve and a female Luer fitting with female reflux valve in combination with two types of syringes;

FIG. 25 is an exploded partial cross-sectional view of various reflux valves in combination with a drip chamber and a Burette chamber;

FIG. 26 is a cross-sectional view of a male Luer fitting with male reflux valve and female Luer fitting with female reflux valve bonded to a Burette chamber;

FIG. 27 is a plan view of a plurality of Luer fittings with reflux valves operably engaged with a stopcock;

FIG. 28 is an exploded plan view of various reflux valves in operable engagement with various types of spikes;

FIG. 29 is an exploded isometric view of a four-way valve with various associated components including Luer fittings with reflux valves;

FIG. 30 is an exploded isometric view of an in-line multiport valve assembly;

FIG. 31 is a cross-sectional view of a male reflux valve in operable engagement with a tapered adapter fitting; and

FIG. 32 is a cross-sectional view of a male reflux valve of the present invention in operable engagement with an enteral fitting.

DESCRIPTION OF THE PREFERRED EMBODIMENT

Referring initially to FIG. 1, an intravenous (IV) infusion container, configured for purposes of disclosure as a bag, is shown and generally designated 10. Preferably thebag 10 is made of a suitable inert, biocompatible, flexible material, such as polyvinylchloride (PVC) or plex dr. It is to be understood, however, that the principles of the present invention can be applied to other types of IV fluid containers, such as semi-rigid containers (not shown), multi-layer bags for holding cell culture (FIG. 6), or glass bottles and vials (FIG. 5).

As shown in FIG. 1, thebag 10 holds a fluid 12 to be infused into a patient 14 through IV line 16. It is to be understood that the IV line 16 may be operably engaged with respective devices, such as roller clamps (not shown) for selectively permitting fluid communication through the IV line 16.

FIG. 1 shows that the IV line 16 is connected to aconventional drip chamber 20, and thedrip chamber 20 is in turn connected to aconventional spike 22. Thespike 22 is engaged with aconventional port 24 of thebag 10. As shown in FIG. 1, theport 24 is essentially a tube that has a first end inserted into an opening in theIV bag 10 at thebottom seam 26 of theIV bag 10. Theconventional port 24 has a membrane (not shown) positioned therein, and thespike 22 pierces the membrane to establish a path for fluid communication between the spike and the interior of the IV bag.

Still referring to FIG. 1, thebag 10 also has a spikeless/needleless port 28 that includes a tube which is inserted into an opening in thebottom seam 26 of thebag 10 and then bonded by means well-known in the art (e.g., ultra-sonic welding, solvent bonding, heat staking, spin welding or rf sealing). Alternatively, the tube of theport 28 can be formed integrally with theIV bag 10, or the tube can be bonded internally to thebag 10.

FIG. 1 further shows that theport 28 includes avalve 30 which is configured as a female luer fitting. Aneedleless syringe 32 can be operably engaged with the spikeless/needleless port 28. Preferably, theneedleless syringe 32 has anend 34 configured as a male luer fitting, to facilitate engagement of thesyringe 32 with the spikeless/needleless port 28. Thesyringe 32 can be used to inject additional fluid into thebag 10. Alternatively, a blunt spike (not shown) having an end configured as a male luer fitting can be engaged with the spikeless/needleless port 28 to establish a passageway for fluid infusion from thebag 10 into an IV line (not shown) and thence into thepatient 14.

While FIG. 1 shows a spikeless/needleless port 28 and aconventional port 24, it is to be understood that additional spikeless/needleless ports (not shown) can be included in thebag 10. It is to be further understood that theconventional port 24 can be omitted from thebag 10, or additional conventional ports Knot shown) included in thebag 10. In any case, theports 24, 28 that extend from thebottom seam 26 of thebag 10 can be formed integrally with thebag 10 or attached to thebag 10 by well-known means, e.g., by rf sealing, ultrasonic welding, heat staking, spin welding, or solvent bonding.

In addition to theports 24, 28 that extend from thebottom seam 26 of thebag 10, FIG. 1 shows that anotherport 36, colloquially known as a "belly button," can be formed in aside surface 38 of thebag 10. Preferably, thebelly button port 36 incudes an opening in theside surface 38 of thebag 10, and avalve 42 is disposed in the opening. A needleless syringe (not shown), e.g., a syringe having a male luer fitting in lieu of a sharp needle, can be engaged with thebelly button port 36 to inject or extract fluid from thebag 10.

Now referring to FIG. 2A, the details of the spikeless/needleless port 28 can be seen. As shown, the spikeless/needleless port 28 includes ahollow tube 44, and thevalve 30 is positioned in thetube 44 to selectively prevent fluid communication through thetube 44. Thevalve 30 includes a rigid, preferably plastic (e.g., PVC)valve body 46 that has afluid inlet 48, afluid outlet 50, and afluid passageway 52 formed in thevalve body 46 between theinlet 48 andoutlet 50. Thevalve body 46 can be a unitary structure, or be made of two or more pieces that are bonded together, as shown. For example, theinlet 48 can be formed from afirst piece 49, theoutlet 50 can be formed from asecond piece 51, and the two pieces can be bonded together by means well-known in the art, e.g., solvent bonding, ultrasonic sealing, or rf welding.

In cross-reference to FIGS. 2A and 3, thevalve 30 also includesvalve member 54 that is disposed in thefluid passageway 52. Specifically, the periphery of thevalve member 54 rests on aseating surface 56 of thevalve body 46 to establish a fluid-tight seal between thevalve member 54 andseating surface 46. In other words, thevalve member 54 is biased to the closed configuration shown in FIG. 2A. Asupport element 58 is formed in thefluid passageway 52 and extends across thefluid passageway 52.

Thesupport element 58 supports thevalve member 54 in the center thereof. To this end, a slight depression may be formed in the center of thevalve member 54 to receive thesupport element 58 and thereby prevent side-to-side motion of thevalve member 54 relative to thesupport element 58. As shown, thesupport element 58 is shaped as a cylinder, but it is to be understood that thesupport element 58 can have other suitable shapes, e.g., thesupport element 58 can have a triangular shape.

Additionally, aretainer element 60 is formed on thevalve body 46 and extends across thefluid passageway 52. As shown, theretainer element 60 is positioned on thevalve body 46 on the opposite side of thevalve member 54 from thesupport element 58. Accordingly, theretainer element 60 holds the center of thevalve member 54 against thesupport element 58.

Still referring to FIGS. 2A and 3, a rigid urgingmember 62 is shown slidably disposed in thefluid passageway 52 for reciprocal movement therein. As shown, the urgingmember 62 has anannular head 64 and askirt 66 that depends from thehead 64. As further shown, theskirt 66 includes a plurality of, preferably two, legs. The urgingmember 62 can be forced against thevalve member 54 by advancing an appropriate connector fitting (not shown), such as a male luer fitting, into thefluid passageway 52 and against the urgingmember 62.

As shown in FIG. 2B, when the urgingmember 62 is forced against thevalve member 54, theskirt 66 of the urgingmember 62 contacts the surface of thevalve member 54. This deforms thevalve member 54, causing the sealing surface of thevalve member 54 to be distanced from theseating surface 56 of thevalve body 46, and thereby permitting fluid communication through thefluid passageway 52. Stated differently, a spikeless/needleless connector can be advanced into thefluid passageway 52 to force the urgingmember 62 against thevalve member 54 and deform thevalve member 54 into an open configuration. When the spikeless/needleless connector is retracted from thefluid passageway 52, the resiliency of thevalve member 54 causes thevalve member 54 to resume its normally closed configuration, shown in FIG. 2A.

Referring back to FIG. 3, a tamper-resistant cap 84 can be engaged with thevalve 30. In one presently preferred embodiment, askirt 85 of thecap 84 has a plurality ofresilient ratchet threads 86. Theratchet threads 86 are configured generally as right triangles, as shown, and permit rotation of thecap 84 in the clockwise direction relative to thevalve 30 to thereby engage thecap 84 with thevalve 30. Thethreads 86 do not, however, permit easy rotation of thecap 84 in the counter clockwise direction. Thethreads 86 ratchetably engageblades 87 that are formed on thefirst piece 49. It is to be understood that thecap 84 can engage any appropriate surface of thefirst piece 49 or other appropriate surface of thevalve 30.

FIGS. 4A and 4B show that thevalve 42 is, in all essential respects, identical to thevalve 30. Specifically, thevalve 42 has avalve body 68 forming afluid passageway 70. Avalve member 72 is positioned in thefluid passageway 70 for selectively blocking fluid communication therethrough. An urgingmember 74 is disposed in thefluid passageway 70 for reciprocal movement therein, and a spikeless/needleless connector (not shown) can be advanced into thefluid passageway 70 against the urgingmember 74 to open thevalve 42.

Cylindrical or pyramidal protrusions 42a can be formed on thevalve 42 for preventing a vacuum lock between the valve member 118 and the first flange 40. Alternatively, grooves (not shown) could be formed in thevalve body 68 for preventing a vacuum lock between thevalve member 72 and thevalve body 68.

Thevalve 42 is attached, as by solvent bonding, spin welding, rf welding, or ultrasonic sealing, to theside 38 of thebag 10. Anopening 76 is formed in theside 38 of thebag 10, for establishing a pathway for fluid communication into and out of thebag 10. Alternatively, an opening (not shown) can be formed in the top or bottom seam of thebag 10, and additional openings (not shown) can be formed in thebag 10.

Theopening 76 can be formed in theside 38 of thebag 10 during manufacture of thebag 10 by cutting out a portion of thebag 10. More preferably, a die cut is made in theside 38 of thebag 10 in a partially circular pattern to form aflap 78. Theflap 78 remains attached to thebag 10 by anuncut nick 80, and aprotrusion 82 is formed on thevalve 42 for urging against theflap 78 to unblock theopening 76 when thevalve 42 is attached to thebag 10. Thereby, theflap 78 does not prevent fluid flow through theopening 76, once thevalve 42 is in place, and theflap 78 does not become detached from thebag 10. This ensures that theflap 78 will not enter the fluid in thebag 10 and thus will not foul any of the IV components valve member discussed above. Alternatively, theflap 78 can be separated from thebag 10 during manufacturing, and theprotrusion 82 omitted from thevalve 42.

Specifically, to disengage thecap 84 from thevalve 30, sufficient torque must be imparted to thecap 84 to strip to ratchetthreads 86. Consequently, once thecap 84 has been removed from thevalve 30, it cannot be reengaged with thevalve 30. Thus, a missing or strippedcap 84 indicates that thecap 84 has been tampered with. It is to be understood that if desired, a new cap (not shown) that is in all essential respects identical to thecap 84 can be engaged with thevalve 30, although the new cap can be a different color than thecap 84.

In the operation of thebag 10, reference is made to FIG. 1. With thebag 10 initially full of fluid to be infused into thepatient 14, thevalves 30, 42 are closed to prevent fluid flow through theports 28, 36. In other words, thevalve members 54, 72 are biased into their normally closed configurations. Also, the membrane within theconventional port 24 prevents fluid flow through theconventional port 24.

A path for fluid communication can be established through any one of theports 24, 28, 36 by advancing an appropriate connector into the particular port. For example, fluid 12 from thebag 10 can be infused into thepatient 14 by advancing a blunt spike (not shown) into the spikeless/needleless port 28. Alternatively, fluid can be added to or extracted from thebag 10 by advancing theend 34 of theneedleless syringe 32 into theport 28 and operating the plunger of thesyringe 32 to inject fluid into thebag 10.

More particularly, as described above, theneedleless syringe 32 is sufficiently advanced into the spikeless/needleless port 28 (and the valve 30) to open thevalve 30.Fluid 12 can then be injected into or extracted from theIV bag 10 through the spikeless/needleless port 28.

Similarly, theconventional spike 22 can be advanced into theconventional port 24 until thespike 22 pierces the membrane within theport 24. This establishes a path for fluid flow through theport 24, spike 22 and IV line 16 into thepatient 14. This fluid flow can be effected by gravity drain or by engaging a peristaltic pump (not shown) with the IV line 16 and pumpingfluid 12 into thepatient 14.

Further, fluid can be injected or extracted from theIV bag 10 by engaging a needleless syringe with thebelly button port 36 and appropriately operating the plunger of the syringe. More specifically, using thebelly button port 36 as an example, the connector portion of the syringe can be advanced into thevalve 42 to open thevalve 42, and the plunger of the syringe then manipulated as appropriate to infuse or extract fluid into thebag 10. The skilled artisan will appreciate that thebelly button port 36 can be used as another site to piggy back a container using a Luer fitting.

When it is no longer necessary to infuse fluid into thebag 10 through the spikeless/needleless port 28, theneedleless syringe 32 is simply retracted from the spikeless/needleless port 28. This causes theresilient valve member 54 to resume its normally closed position to thereby block fluid flow through the spikeless/needleless port 28. Also, after fluid has been infused or extracted as appropriate from thebag 10 through thebelly button port 36, the needleless syringe is simply retracted from thevalve 42. This causes theresilient valve member 72 to resume its normally closed configuration, thereby preventing fluid flow through thebellow button port 36. FIG. 1A shows that aglass vial 200 can have aneedleless port 202. Avalve 204 which is in all essential respects identical to thevalve 30 can be positioned in theport 202, to selectively establish a needleless connector through which fluid can pass into or out of thevial 200.

Now referring to FIGS. 5-11, several embodiments of liquid medicament bags in accordance with the present invention are shown. FIG. 5 shows that a liquid medicament bag 300 has a firstmulti-laminate side 302, a secondmulti-laminate side 304, and aseam 306 that is established at the juncture of thesides 302, 304. Thus, thesides 302, 304 withseam 306 establish a container of the type well-known in the art for holding, e.g., liquid medicament, cell culture, and other biotech fluids. The skilled artisan will accordingly appreciate that the material and thickness of the laminated layers are selected for strength, puncture resistance, gas permeability, and compatibility with the fluid contained in the bag 300. For example, FIG. 6 shows that theside 302 has twolayers 302a, 302b. It is to be appreciated that theside 302 can have additional layers, if desired.

A rigidplastic valve assembly 308 is fixedly positioned on theseam 306 during manufacture by means well-known in the art, e.g., by rf sealing, spin welding, or ultrasonic welding, and thesides 302, 304 of the bag 300 are likewise connected, as indicated by abond line 303. Theassembly 308 in the perspective view shown has a catenary shape when looked at from above.

FIGS. 6 and 7 show that thevalve assembly 308 is "H"-shaped in transverse cross-section, and has first andsecond openings 310, 312 which are established byflanges 310a, 310b. As shown, theflanges 310a, 310b are bonded to thesides 304, 302, respectively, of the bag 300. A firstreflex valve 314 is positioned in thefirst opening 310 and a secondreflex valve 316 is positioned in thesecond opening 312.

Thefirst valve 314 is in all essential respects identical in construction to thevalve 30 valve member disclosed above, except that thefirst valve 314 hasgrooves 315 formed in place of the protrusions 42a shown in FIGS. 2A and 2B. It is to be understood that thegrooves 315 fulfill the same function as the protrusions 42a, i.e., thegrooves 315 prevent a vacuum lock from being established between avalve member 317 and avalve body 319.

As shown best in FIG. 7, thesecond valve 316 also is identical to thevalve 30, except that thesecond valve 316 has amale valve element 318. More particularly, themale valve element 318 has acylindrical skirt 320 and a contact surface, preferably a shapedhead 322 which extends radially outwardly from theskirt 320. Alternatively, thevalve element 318 can have a non-rounded shape.

As shown, thesecond valve 316 is configured as a male luer fitting. Consequently, a female luer fitting 324 (FIG. 8) can be engaged with thevalve 316 such that a taperedinner surface 326 of the female luer fitting 324 urges against thehead 322 to move thesecond valve 316 to the open configuration.

While FIGS. 6 and 7 show avalve assembly 308 having twovalves 314, 316 positioned therein, it is to be understood that theassembly 308 can have one or more openings, and that one or more of the openings can have a piercable membrane positioned therein, if desired. It is to be further understood that themale valve 316 can be used in place of the valves previously valve member losed, e.g., themale valve 316 can be used in place of thevalve 30 shown in FIGS. 2A and 2B.

FIG. 9 shows that a valve assembly, generally designated 330, can have a configuration familiarly referred to as a "wedge" configuration. Specifically, in the view shown in FIG. 9, twoengagement flanges 336, 338 depend downwardly from abottom surface 340 of theassembly 330. It is to be understood that in accordance with the present invention, theflanges 336, 338 are positioned between the sides of a liquid medicament bag, i.e., in the seam of the bag, and are connected thereto by means well-known in the art. Like thevalve assembly 308 shown in FIGS. 5-8, thevalve assembly 330 has two or morereflex valves 342, 344 disposed in respective openings formed by theassembly 330.

FIG. 10 shows that avalve assembly 346 has a gently curved saddle shape bottom surface 348 for conforming to abag 350. Theassembly 346 is and attached to thebag 350 by means well-known in the art, e.g., solvent bonding, rf sealing, heat staking, or ultrasonic welding. Like theassemblies 308, 330 shown in FIGS. 5-9, theassembly 346 shown in FIG. 10 has two ormore valves 352, 354. Also, eachvalve 352, 354 can have a respective tamper-resistant cap 356, 358 which is configured to engage a luer fitting. Thecaps 356, 358 can have a well-known configuration for resisting tampering, e.g., thecaps 356, 358 can have plastic ratchet threads which strip during removal of thecap 356, 358 from its associatedvalve 352, 354.

FIG. 11 shows a valve assembly, generally designated 360, which has a socalled boat shape, and is accordingly referred to in the art familiarly as a "boat". Theassembly 360 also has twoopenings 362, 364 and twovalves 366, 368 respectively positioned in theopenings 362, 364. TheValves 366, 368 can be female or male valves. In the embodiment shown,th& valve 366 is a male valve configured like thevalve 316 shown in FIGS. 7 and 8, while thevalve 368 is a female valve configured like thevalve 30 shown in FIGS. 2A and 2B.

As can be appreciated in reference to FIG. 11, theassembly 360 has ahull surface 370 which is generally shaped like the gently rounded hull of a boat, and which consequently can be positioned between the juncture of two sides of abag 372, and then attached to the bag by means well-known in the art. In other words, thehull surface 370 of theassembly 360 can be positioned in the seam of a liquid medicament bag.

In addition to the openings valve member discussed above, theassemblies 308, 330, 360 can have additional openings (not shown) which can be blocked by respective reflex valves or by pierceable membranes.

FIGS. 12 and 13 show multi-layer medicament bags having multiple individual tubular connectors for receiving associated valves. More specifically, FIG. 12 shows a bag 361 which has a first tubular connector 363 and a second tubular connector 365. The first tubular connector 363 includes a hollow cylindrical tube 367 which is bonded to thebag 360 by means well-known in the art.

A hollow male luer connector 369 is closely received in thetube 366, and a female luer fitting 373 can be engaged with the male luer connector 369. A valve 371 which is in all essential respects identical to thevalve 316 shown in FIG. 7 is bonded to the female luer fitting 373.

Likewise, the second tubular connector 365 includes a hollowcylindrical tube 374 which is bonded to the bag 361 by means well-known in the art. A hollowfemale luer connector 376 is closely received in thetube 374, and a male luer fitting 378 can be engaged with thefemale luer connector 376. Avalve 380 which is in all essential respects identical to thevalve 314 shown in FIG. 6 is bonded to the male luer fitting 378. IV lines or other components, e.g., spikes and drip chambers (not shown) having luer fittings can be engaged with thevalves 371, 380 to selectively establish fluid flow through the connectors 363, 365 in accordance with the principles set forth above.

FIG. 13 shows that amulti-layer medicament bag 382 has a plurality of resilient plastictubular connectors 384, 386. Theconnector 384 can closely receive avalve 388 which is in all essential respects identical to thevalve 28 shown in FIGS. 2A and 2B. If desired, thevalve 388 can be bonded to theconnector 384.

FIG. 13 also shows that anintermediate connector tube 390 can be bonded to theconnector 386, and a hollow Y-fitting 392 in turn bonded to theintermediate connector tube 390. If desired, anextender tube 393 can be connected to a first leg tube 392a of the Y-fitting 392, and a first luer bulkhead fitting 394 can be advanced into theextender tube 393. A second luer bulkhead fitting 396 can be advanced into asecond leg tube 392b of the Y-fitting 392 or extension tubes (not shown) that are connected to thesecond leg tube 392b.

Each of theluer bulkhead fittings 394, 396 has respective ratchet rings 394a, 396a which are configured as shown for permitting theluer bulkhead fittings 394, 396 to be advanced into theirrespective tubes 393, 392b, and for preventing theluer bulkhead fittings 394, 396 from being easily retracted from theirrespective tubes 393, 392b. If desired, the luer bulkhead fitting 394 can also include a locking ring assembly, generally designated 398, which includes a threadedbody 400, a locking ring 402 threadably engaged with thebody 400, and abacking ring 404. Theluer bulkhead fittings 394, 396 can advantageously be similar to any one of the luer bulkhead fittings made by Value Plastics, Inc. of Fort Collins, Colo.

A malereflex valve 406 which is in all essential respects identical to thevalve 316 shown in FIG. 7 is bonded by means well-known in the art to the first bulkhead luer fitting 394. Likewise, a femalereflex valve 408 which is in all essential respects identical to thevalve 314 shown in FIG. 6 is bonded by means well-known in the art to the second bulkhead luer fitting 396. IV lines or other components, e.g., spikes and drip chambers (not shown) having luer fittings can be engaged with thevalves 388, 406, 408 to selectively establish fluid flow through theconnectors 384 and Y-leg tubes 392a, 392b (and extension tubes thereof, e.g., the tube 393) in accordance with the principles set forth above.

FIG. 14 shows avalve 450 which is a male reflux valve configured like thevalve 316 shown in FIG. 7. Accordingly, thevalve 450 includes amale Luer connector 452. In accordance with principles well known in the art, themale Luer connector 452 is formed with an outer frusto-conical wall 454 which tapers slightly radially inwardly from aproximal end 456 to adistal end 458 of theconnector 452.

As shown, thevalve 450 is bonded to an intravenous (IV)component 460. It is to be understood that thevalve 450 can be attached to thecomponent 460 by means well known in the art, e.g., solvent bonding, RF sealing, heat staking, spin welding, or sonic welding. As will be more fully valve member disclosed below, theIV component 460 can be any IV component for which it is desired to selectively establish fluid communication into or out of. For example, theIV component 460 can be an IV container such as a bag, or a syringe, spike, fluid line, drip chamber, connector fitting, filter, stopcock, Burette chamber, or adapter fitting. Consequently, the skilled artisan will appreciate that thevalve 450 can be used in a large number of applications, including IV container devices and sets, enteral feeding, other biotechnology applications, other medical applications including cardiovascular, urology, anesthesiology and chemotherapy.

FIG. 15 shows amale reflux valve 462 which is bonded to a female Luer fitting 464. Afluid passageway 466 is established by thevalve 462 and the female Luer fitting 464, and fluid communication through thefluid passageway 466 is selectively established by manipulating amale valve element 468 of thevalve 462 as described previously. It is to be understood that the female Luer fitting 464 can include a female reflux valve as described previously.

FIG. 16 shows amale reflux valve 470 which is bonded to aconnector 472, and theconnector 472 hascylindrical walls 474, 476. Theexternal walls 476 or theinternal walls 474 of theconnector 472 can in turn be bonded to another IV component. Thereflux valve 470 selectively establishes fluid flow through the fluid passageway which is established by theconnector 472.

FIG. 17 shows amale reflux valve 478 which is bonded to acheck valve 480, and thecheck valve 480 is in turn bonded to anIV component 482. As shown, the male reflux valve includes amale valve element 484, areflux disk 486, asupport element 488 for supporting thereflux disk 486 in the center thereof, and aretainer element 490. Thecheck valve 480 includes acheck valve body 492 and acheck valve disk 494. Also, a checkvalve support element 496 is provided for supporting thecheck valve disk 494 in the center thereof. It can be appreciated in reference to FIG. 17 that thesupport element 488 functions as a retainer element for thecheck valve disk 494.

It will be further appreciated that thecheck valve disk 494 permits fluid flow through afluid passageway 498 only in the direction indicated by thearrow 500 and substantially prevents fluid flow in a direction opposite thearrow 500. This is true regardless of whether themale valve element 484 has been urged into thereflux disk 486 to form the disk. Accordingly, the combination of structure shown in FIG. 17 results in a modified check valve in which fluid flow only in the direction of thearrow 500 is permitted, only when themale valve element 484 is urged against thereflux disk 486. It is to be understood that in some applications, themale reflux valve 478 can be replaced by a female reflux valve (not shown).

FIG. 18 shows amale reflux valve 502 which is engaged with abarbed connector 504 that is formed with a plurality of frusto-conical shapedbarbs 506, with the barbs being configured for securely engaging the lumen of another IV component (not shown), such as an IV line. Other barb shapes may also be used. Themale reflux valve 502, in accordance with the valve member discussion above, selectively establishes fluid communication through acylindrical passageway 508 which is established by thebarbed connector 504.

FIG. 19 shows amale reflux valve 510 which is connected to a steppedconnector 512 having a plurality ofsteps 514, with the steps being configured for securely engaging the lumen of another IV component (not shown), such as an IV line. Thereflux valve 510 selectively establishes fluid flow through acylindrical fluid passageway 516 which is established by the steppedconnector 512. It is to be understood that theconnector 512 can have a continuously tapered outer wall instead of the steps shown.

FIG. 20 shows a male reflux valve, generally designated 518, which includes a male valve element orfemale valve element 520 and avalve body 522. As shown, thevalve element 520 includes acontact flange 524 defining aflat contact surface 526 and abody surface 528 that is opposed to thecontact surface 526. As shown in FIG. 20, thebody surface 528 defines an angle αrelative to thecontact surface 526. More specifically, thebody surface 528 defines an angle α relative to thecontact surface 526 of between about 5° and 75°.

Likewise, thevalve body 522 is formed with anabutment surface 530 which is generally parallel to thebody surface 528 of thecontact flange 524. It is to be understood that theabutment surface 530 andbody surface 528 interlock with each other to more securely hold thevalve element 520 within thevalve body 522.

FIG. 21 shows amale reflux valve 534 which is connected to aconnector 536 for selectively establishing fluid flow through acylindrical fluid passageway 538 defined by theconnector 536. As shown, theconnector 536 has a taperedsegment 540 and a threadedsegment 542 for engaging a complementarily threaded IV component.

FIG. 22 shows amale reflux valve 544 which is disposed in aport 546 of a so-called "T"-site connector 548. The T-site connector 548 defines a main fluid passageway 550 and asecondary fluid passageway 552, and themale reflux valve 544 can be manipulated as described above to selectively permit fluid communication through thesecondary fluid passageway 552 of the T-site connector 548.

FIG. 23 shows amale reflux valve 554 which is disposed in aport 556 of a so-called "Y"-site connector 558. As shown, the Y-site connector 558 defines a maincylindrical fluid passageway 560 and asecondary fluid passageway 562. Thevalve 554 can be operated as valve member disclosed above to selectively block fluid communication through thesecondary passageway 562 of the Y-site connector 558.

FIG. 24 is an exploded view of a male reflux valve, generally designated 564, and a female reflux valve, generally designated 566. As valve member disclosed above, themale reflux valve 564 includes avalve body 568 which is configured as a male Luer fitting, while thefemale reflux valve 566 includes avalve body 570 generally configured as a female Luer fitting.

Each of thevalves 564, 566 includes its own disk, represented by thesingle disk 572 shown in FIG. 24. Either of thevalves 564, 566 can be engaged in either one of theports 574, 576 ofrespective syringes 578, 580. The skilled artisan will appreciate in reference to FIG. 24 that thesyringe 578 is a shaft-style syringe and accordingly includes ashaft 582 connected to aproximal plunger 583. On the other hand, thesyringe 580 is a syringe of the style made by Smith and Nephew, and accordingly has no shaft connected to the plunger. In accordance with principles valve member disclosed above, fluid communication through theports 574, 576 of thesyringes 578, 580 can be selectively established by either one of thevalves 564, 566.

FIG. 25 shows a plurality of valving arrangements which can be used to selectively block fluid communication through the ports of adrip chamber 584 and a Burette chamber 586. More specifically, thedrip chamber 584 has aport 588 which is established by an outwardly protrudingcylindrical wall 590. Thedrip chamber 584 further includes a cone or sock filter 592 which covers anoutlet port 594. It is to be understood that the filter 592 can have other configurations known in the art, e.g. as shown in FIG. 25.

Theinlet port 588 of thedrip chamber 584 can receive one of a plurality of valves for selectively blocking fluid communication through theport 588. More specifically, a firstmale reflux valve 596 can have abonding segment 598 which is bonded to thewalls 590 of theinlet port 588. It is to be understood that themale reflux valve 596, like the other male reflux valves valve member disclosed herein, is substantially identical in configuration to thereflux valve 316 shown in FIG. 7.

Alternatively, a firstfemale reflux valve 600 having anengagement segment 602 can be disposed in theinlet port 588 of thesyringe 584, with theengagement segment 602 being bonded to thewalls 590 of theinlet port 588. It is to be understood that the firstfemale reflux valve 600 is substantially identical in configuration to the other female reflux valves previously described, e.g. thevalve 30 shown in FIG. 1. Furthermore, a secondfemale reflux valve 604 can be disposed in theport 588 of thedrip chamber 584 to selectively establish fluid communication through theinlet port 588. The secondfemale reflux valve 604 may be configured differently than the firstfemale valve 600, e.g. the secondfemale valve 604 may be one of the IV valves made by Clavey or Halkey-Roberts.

Still referring to FIG. 25, the Burette chamber 586 has afirst inlet port 606 which is defined by an outwardly protrudingcylindrical wall 608. It can be appreciated in reference to FIG. 25 that any one of thevalves 596, 600, 604 may be disposed in thefirst inlet port 606 of the Burette chamber 586 to selectively block fluid communication therethrough in accordance with principles valve member disclosed above. Furthermore, FIG. 25 shows that the Burette chamber 586 has second andthird inlet ports 610, 612 and afourth inlet port 614. As shown, thefourth inlet port 614 includes asupport element 616, the function of which has been described previously in relation to supporting a deformable valve member of the present invention.

Accordingly, thesupport element 616 supports a deformableresilient disk 618 which can be the disk of amale reflux valve 620 or afemale reflux valve 622 under the principles valve member disclosed previously. Thus, it will be understood that thefourth inlet port 614 of the Burette chamber 586 can be configured as a portion of the valve assembly for either one of thevalves 620, 622.

Now referring to FIG. 26, a filter chamber, generally designated 624, has afirst port 626, asecond port 628, and achamber 630 formed therebetween. As shown, thechamber 630 is catenary-shaped in cross-section. Also, a disk-shapedfilter 632 is disposed in the catenary-shapedchamber 630.

A reflux valve in accordance to the present invention can be disposed in either one or both of theports 626, 628. In the embodiment shown in FIG. 26, amale reflux valve 634 is disposed in thesecond port 628, while a femalereflex valve 636 is disposed in the firstfluid port 626. In accordance with the principles of the present invention valve member disclosed above, either one or both of thereflux valves 634, 636 may be operated to selectively establish fluid communication through itsrespective port 628, 626 and into the catenary-shapedchamber 630.

FIG. 27 shows an IV stopcock, generally designated 638. In accordance with principles well known in the art, thestopcock 638 includes a central fluid passageway that is covered by acover plate 640, and an operatinghand wheel 642. Additionally, thestopcock 638 can include at least two ports, and can include additional ports. In the embodiment shown in FIG. 27, thestopcock 638 includes first, second andthird ports 644, 646, 648. A respective reflux valve is disposed in each one of theports 644, 646, 648 to selectively establish fluid communication through the port. More particularly, a firstfemale reflux valve 650 is disposed in thefirst port 644, amale reflux valve 652 is disposed in thesecond port 646, and a secondfemale reflux valve 654 is disposed in thethird port 648. The first and secondfemale reflux valves 650, 654 are in all essential respects identical in configuration to thereflux valve 30 shown in FIG. 1, while themale reflux valve 652 is in all essential respects identical to themale reflux valve 316 shown in FIG. 7. It is to be further understood that one or more of theports 644, 646, 648 may not include a reflux valve, and that for the embodiment shown in FIG. 27, i.e. astopcock 638 having three ports, one of the ports will contain a male reflux valve while the remaining ports will contain female reflux valves.

Now referring to FIG. 28, the skilled artisan will appreciate that the reflux valves of the present invention can be disposed in various types of spikes for selectively establishing fluid communication through the spikes. More particularly, a firstfemale reflux valve 656 can be disposed in anoutlet port 658 of anonvented spike 660. Also, the firstfemale reflux valve 656 can be disposed in theoutlet port 662 of a first ventedspike 664. Moreover, the firstfemale reflux valve 656 can be disposed in anoutlet port 666 of a second type of ventedspike 668. In accordance with the present invention, the firstfemale reflux valve 656 is configured substantially identically to thereflux valve 30 shown in FIG. 1 and can be fixedly engaged in any one of thespikes 660, 664, 668 by means well known in the art valve member disclosed above.

Furthermore, amale reflux valve 670 which is in all essential respects identical in configuration to thereflux valve 316 shown in FIG. 7 can be engaged with any one of theoutlet ports 658, 662, 666 of therespective spikes 660, 664, 668. Additionally, a secondfemale reflux valve 672 can be engaged with any one of theports 658, 662, 666 of therespective spikes 660, 664, 668. As intended by the present invention, the secondfemale reflux valve 672 is substantially identical to thefemale reflux valve 604 shown in FIG. 25.

Now referring to FIG. 29, a novel multiport IV valve of the present invention, generally designated 674, can be seen. As shown, themultiport valve 674 includes a first port 676 which is generally cylindrically shaped, and asecond port 678 which is also generally cylindrically shaped and is configured as a female Luer fitting. As can be appreciated in reference to

FIG. 29, the first andsecond ports 676, 678 are coaxial and establish a main fluid passageway therebetween. A firstmale Luer valve 680 is fixedly engaged with the first port 676 for selectively blocking fluid communication therethrough.

FIG. 29 additionally shows that themultiport valve 674 includes third, fourth, fifth andsixth ports 682, 684, 686, 688, all of which are generally cylindrically shaped. As shown, the third andfifth ports 682, 686 are coaxial with each other. Likewise, the fourth andsixth ports 684, 688 are coaxial with each other. Each of the third throughsixth ports 682, 684, 686, 688 defines a respective fluid pathway, and fluid communication through the fluid pathway can be selectively established or otherwise effected as valve member disclosed below.

For example, afemale reflux valve 690 can be disposed in the third fluid port 682 for selectively establishing fluid communication through the port 682 and into themain fluid passageway 679 in accordance with principles valve member disclosed previously. Moreover, a combination male reflux valve-check valve 692, 694, which is substantially identical to thevalve 478, 480 shown in FIG. 17, can be disposed in the fourthfluid inlet port 684 of themultiport valve 674. If desired, themale reflux valve 692 can be replaced with a female reflux valve (not shown) which is substantially identical to thefemale reflux valve 30 shown in FIG. 1.

Additionally, fluid communication through thefifth inlet port 686 can be permanently blocked if desired by bonding aplug 696 within theport 686 by means well known in the art. Alternatively, the fifthfluid inlet port 686 can hold a fluid filter, e.g. afilter 698. As shown, thefilter 698 includes afilter element 700 having amembrane 702 through which air can pass. Thefilter 698 also includes aplug element 704 which engagesfilter element 700 and which holds thefilter element 700 within the sixthfluid port 686.

Now referring to FIG. 30, an inline multiport valve is shown, generally shown 710. As shown, thevalve 710 includes an elongated, generally parallelepiped-shapedvalve body 712 that is formed with afluid inlet port 714 and afluid outlet port 716. Thefluid inlet port 714 is configured as a female Luer fitting and thefluid outlet port 716 is configured as a male Luer fitting. A generally cylindrical mainfluid passageway 718 is established through thevalve body 712 between theports 714, 716.

Additionally, thevalve body 712 is formed with two to six fluid inlet ports. In the embodiment shown in FIG. 30, thevalve body 712 includes first through thirdfluid inlet ports 720, 722, 724. One or more reflux valves may be positioned in theports 720, 722, 724 to selectively establish fluid communication therethrough. More particularly, a firstmale reflux valve 726 is positioned in thefirst port 724, a secondmale reflux valve 728 is positioned in thesecond port 726, and a thirdmale reflux valve 730 is positioned in thethird port 724. The firstmale reflux valve 726 can include acheck valve 732 having adeformable valve member 734 to establish a reflux-check valve like the structure shown in FIG. 17.

When theinline multiport valve 710 includes only three ports, a solid, continuous parallelepiped-shapedbottom plate 735 is rf sealed or ultrasonically welded to thevalve body 712 opposite the first throughthird ports 720, 722, 724. On the other hand, theinline multiport valve 710 may include additional ports, in which case thebottom plate 735 is replaced with a port plate 737 which is formed with fourth throughsixth ports 736, 738, 740. Amale reflux valve 742 can be positioned in thesixth port 740, afemale reflux valve 744 can be positioned in thefifth port 738, and afilter 746 which is similar to thefilter 698 shown in FIG. 29 can be positioned in thefourth port 736. Thefourth port 736 can include the mounting bracket, reflux valves, filter, plug, and check valve options shown in FIG. 29.

FIG. 31 shows that a male reflux valve, generally designated 750, can include amale valve element 752 and a frusto-conical shapedvalve body 754, which is formed with atapered wall 755. It is to be understood that thevalve body 754 is configured as an adapter fitting, e.g., a Luer catheter adapter, a 9/32 adapter, or 3/16 adapter, for interconnecting two IV components having inside diameters differing from each other.

Thevalve 750 has aport 756 defined by an innercylindrical wall 758 which is surrounded by an outercylindrical wall 760. Either of thewalls 758, 760 can be bonded to an IV component (not shown) by means well-known in the art.

FIG. 32 shows a valve, generally designated 762, having a frusto-conicalshaped body 764 formed with atapered wall 765 for configuring the valve 762 as an enteral feeding adapter. The valve 762 also includes a hollowcylindrical valve element 766 having an outer wall 766a which tapers toward aninner wall 766b near a distal end 766c of theelement 766. For purposes of the present invention, thevalve element 766 includes askirt 766d disposed in thevalve body 764 and an engagement surface 766e that extends beyond the fluid passageway established by thevalve body 764. Also, the valve 762 includes a deformableresilient valve member 768, and thevalve element 766 can be urged against thevalve member 768 to deform the valve member and thereby permit fluid communication through the valve 762.

The valve 762 has aport 770 defined by an innercylindrical wall 772 which is surrounded by an outercylindrical wall 774. Either of thewalls 772, 774 can be bonded to an IV component (not shown) by means well-known in the art.

While the particular needleless valve for use with intravenous infusion components as herein shown and described in detail is fully capable of attaining the objects stated above, it is to be understood that it is but the presently preferred embodiments of the present invention, and that the scope of the present invention is accordingly to be ignited by nothing other than the appended claims.

Claims (13)

I claim:

1. An IV port, comprising:

an IV container selected from the group of containers consisting of flexible IV bags and rigid IV container;

at least one port body extending from the IV container;

a valve body operably engaged within the port body, the valve body defining a fluid passageway for permitting fluid flow into and out of the IV container, the valve body being configured as a female luer fitting; and

a valve member positioned in the valve body for selectively blocking fluid through the valve body,

the valve member defining an outer periphery that is uninterrupted within the periphery, the valve member being disposed in the valve body and biased to a closed configuration, wherein a passageway for fluid communication is not established through the valve body,

the valve member being movable to an open configuration when a mating component is engaged, wherein two-way fluid communication through the valve body is permitted.

2. The port of claim 1, wherein the port body is configured in the shape referred to as a "Wedge" port.

3. The port of claim 1, wherein the port body is configured in the shape referred to as a "Boat port".

4. The port of claim 1, wherein the port body is configured in the shape referred to as a "Saddle" port.

5. The port of claim 1, wherein the port body is configured in the shape referred to as a "Belly Button" port.

6. The port of claim 1, wherein the port body is configured as a check valve, in which a resilient valve member biased to the first configuration, wherein a passageway for fluid communication is not established through the valve body, the member being deformable to a second configuration, wherein fluid communication through the body is permitted.

7. The port of claim 1, wherein the valve body has a continuous smooth outer surface defining a periphery, the valve body being in contact with the IV container entirely around the periphery to facilitate leak-free engagement between the bag and the valve body.

8. The port of claim 7, wherein the IV container is a bag, and the port further comprises a tube disposed in the bag, the valve body being received in the tube for facilitating leak-free engagement between the bag and the valve body.

9. A port comprising:

a container selected from the group of containers consisting of flexible IV bags and rigid IV containers;

at least one port body extending from the IV container, the port body configured as a wedge port, boat port, or a saddle port;

a valve body operably engaged within the port body, the valve body defining a fluid passageway for permitting fluid flow into and out of the IV container, the valve body being configured as a luer fitting;

a valve member positioned in the valve body for selecting blocking fluid through the valve body, the valve member defining an outer periphery,

the valve member being disposed in the valve body and biased to a closed configuration, wherein a passageway for fluid communication is not established through the valve body, the valve member being movable to an open configuration when the leur is engaged, wherein two-way fluid communication through the valve body is permitted.

10. The port of claim 9 wherein the luer is configured as a female luer.

11. The port of claim 9 wherein the luer is configured as a male luer, with a male valve element disposed in the valve body and defining an engagement surface extending outwardly beyond the valve body for contacting a connector to cause the valve element to move the valve member to an open configuration.

12. A port comprising:

a container selected from the group of containers consisting of flexible IV bags and rigid IV containers;

a valve body defining a port for permitting fluid flow into and out of the IV container, the valve body being configured as a luer fitting;

at least one port body configured as a belly button port;

a valve member positioned in the valve body for selectively blocking fluid flow through the valve body, the valve member defining an outer periphery that is uninterrupted within the periphery, the valve member being disposed in the valve body and biased to a closed configuration, wherein a passageway for fluid communication is not established through the valve body, the valve member being movable to an open configuration when the luer is engaged, wherein two-way fluid communication through the valve body is permitted.

13. A port according to claim 12, wherein the luer is configured as a male luer.

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